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Claims for Patent: 6,102,254

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Claims for Patent: 6,102,254

Title: Pharmaceutical compositions in semisolid form and a device for administration thereof
Abstract:A pharmaceutical delivery system for oral administration of a pharmaceutical agent comprises: (a) a squeezable container having an outlet defining a flow channel, (b) a channel closure device adapted to selectively close or open the flow channel; and (c) within the container, at least one dose of a pharmaceutical composition, the composition being a semisolid material that is storage stable, and consists of mutually compatible components, the components comprising (i) an effective amount of an orally active pharmaceutical agent useful for systemic treatment, and (ii) a palatable pharmaceutically acceptable vehicle, comprising a liquid base selected from the group consisting of water, propylene glycol, polyethylene glycol, glycerin, and mixtures thereof, a thickening agent selected from the group consisting of starch, modified starch, sodium carboxymethyl cellulose, microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, other cellulose derivatives, acacia, tragacanth, pectin, gelatin, polyethylene glycol, and water-soluble carboxyvinyl polymers, the pharmaceutical composition having a consistency which allows the composition to be squeezed by manual pressure through the flow channel, whereby in response to pressure on the container when the flow channel is open, a predetermined unit dose of the pharmaceutical composition can be easily squeezed from the container into a receptacle, measured, and administered orally without spilling any of the composition from the container or the receptacle.
Inventor(s): Ross; Malcolm Stewart Frank (Tel Aviv, IL)
Assignee: Taro Pharmaceutical Industies Ltd. (Haifa Bay, IL)
Application Number:09/251,155
Patent Claims: 1. A pharmaceutical delivery system for oral administration of a pharmaceutical agent, comprising:

(a) a squeezable container having an outlet defining a flow channel,

(b) a channel closure device adapted to selectively close or open the flow channel; and

(c) within the container, at least one dose of a pharmaceutical composition, the composition being a semisolid material that is storage stable, and consists of mutually compatible components, the components comprising

(i) an effective amount of an orally active pharmaceutical agent useful for systemic treatment, and

(ii) a palatable pharmaceutically acceptable vehicle, comprising

a liquid base selected from the group consisting of water, propylene glycol, polyethylene glycol, glycerin, and mixtures thereof,

a thickening agent selected from the group consisting of starch, modified starch, sodium carboxymethyl cellulose, microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, other cellulose derivatives, acacia, tragacanth, pectin, gelatin, polyethylene glycol, and water-soluble carboxyvinyl polymers,

the pharmaceutical composition having a consistency which allows the composition to be squeezed by manual pressure through the flow channel,

whereby in response to pressure on the container when the flow channel is open, a predetermined unit dose of the pharmaceutical composition can be easily squeezed from the container into a receptacle, measured, and administered orally without spilling any of the composition from the container or the receptacle.

2. A system according to claim 1 wherein the composition further comprises hydrogenated glucose in an amount greater than about 6.5%.

3. A system according to claim 1 wherein the vehicle consists essentially of the liquid base, the thickening agent, and optionally sweetener, flavoring, preservative, buffer, and solubilizing agent.

4. A system according to claim 1 wherein the composition has a Brookfield viscosity of about 7500 to about 40,000 cps at about 25.degree. C. at a spindle speed of 10 rpm.

5. A system according to claim 1 wherein the container is a flexible tube.

6. A system according to claim 1 further comprising a receptacle positioned to receive material dispensed from the channel, whereby the configuration of the container, channel closure device, and receptacle and the consistency of the formulation are selected so that in response to pressure on the container when the flow channel is open, a predetermined unit dose of the pharmaceutical composition can be easily squeezed by manual pressure from the container through the flow channel into the receptacle, measured, and administered orally without spilling any of the composition from the container or the receptacle.

7. A system according to claim 6, wherein the receptacle is a spoon bowl connected to the container positioned at the flow channel, sized to hold a unit dose of the pharmaceutical composition.

8. The system of claim 1, wherein the liquid base comprises propylene glycol and glycerin, and the thickening agent comprises a water soluble carboxyvinyl polymer.

9. The system of claim 8, wherein the concentration of propylene glycol and glycerin is about 29%, and the concentration of the carboxyvinyl polymer is up to about 1%.

10. The system of claim 1, wherein the liquid base comprises glycerin and sorbitol, and the thickening agent comprises sodium carboxymethylcellulose and microcrystalline cellulose.

11. The system of claim 10, wherein the sorbitol is present as a solution of about 70% in water, the concentration of glycerin and sorbitol solution is about 40%, the concentration of the carboxymethylcellulose is about 2.4%, and the concentration of the microcrystalline cellulose is about 0.9%.

12. The system of claim 1, in which the channel closure device comprises a valve.

13. The pharmaceutical delivery system of claim 1, wherein the liquid base is in an amount of about 45 weight-percent to about 95 weight-percent, and the thickening agent is an amount of about 1 weight-percent to about 55 weight-percent.

14. The system of claim 1, wherein the liquid base is selected from water, propylene glycol, glycerin or a mixture thereof.

15. The system of claim 1, comprising multidoses of the pharmaceutical composition.

16. The system of claim 1, wherein the thickening agent is a cellulose derivative in an amount of about 2.4 to 3.3 weight % by volume.

17. The system of claim 1, wherein the thickening agent is a polyethylene glycol in an amount of about 72 to 85 weight % by volume or a mixture of polyethylene glycol in an amount of about 10 to 25 weight % by volume and a cellulose derivative in an amount of about 2.5 to 3.3 weight % by volume.

18. The system of claim 1, wherein, the pharmaceutical agent is selected from a member of the group consisting of an analgesic, non-steroidal anti-inflammatory, antihistamine, cough suppressant, expectorant, bronchodilator, anti-infective, CNS active drug, cardiovascular drug, antineoplastic, cholesterol-lowering drug, anti-emetic, vitamin, mineral supplement and fecal softener.

19. The system of claim 1, wherein the pharmaceutical agent is selected from a member of the group consisting of acetaminophen, aspirin, ibuprofen, diphenhydramine, dextromethorphan, quafenesin, pseudoephedrine, carbidopa, levodopa, terfenadine, ranitidine, ciprofloxacin, triazolam, fluconazole, propranolol, acyclovir, fluoxetine, enalapril, diltiazem, lovastatin and a pharmaceutically acceptable salt or ester thereof.

20. A system according to claim 1 wherein the composition has a Brookfield viscosity of 2500 to 70,000 cps.

21. A system according to claim 1 wherein the composition has a Brookfield viscosity of 3500 to 65,000 cps.

22. A system according to claim 1 wherein the composition has a Brookfield viscosity of 6000 to 9000 cps.

23. A system according to claim 1 wherein the composition has a Brookfield viscosity of 7500 to 40,000 cps.

24. A system according to claim 1 wherein the liquid base comprises propylene glycol in an amount up to 25%.

25. A system according to claim 1 wherein the liquid base comprises glycerin in an amount of 4% to 30%.

26. A system according to claim 1 wherein the thickening agent comprises 1%

of a water-soluble carboxyvinyl polymer.

27. A system according to claim 1 wherein the pharmaceutical agent is dissolved.

28. A system according to claim 1 wherein the pharmaceutical agent is suspended.

29. The system of claim 8, wherein the concentration of the carboxyvinyl polymer is 1%.

30. A pharmaceutical delivery system comprising:

(a) at least one dose of a storage stable, semisolid pharmaceutical composition comprising an effective amount of a pharmaceutical agent useful for systemic treatment in a pharmaceutically acceptable vehicle, the vehicle comprising a liquid base and a thickening agent in an amount effective to provide a Brookfield viscosity of about 2500 to 70,000 cps at about 25.degree. C. and a spindle speed of about 10 rpm;

(b) means for containing and dispensing substantially all of the pharmaceutical composition upon manual pressure; and

(c) means for dispensing the composition connected to the container means, the dispensing means comprising a channel communicating with the containing means and having an internal diameter of from about 0.1 mm to about 5 mm, and means for reversibly sealing the channel, having sealed and open positions.

31. The delivery system of claim 30, further comprising means for receiving a unit dose of the composition, whereby in response to pressure on the means for containing, when the sealing means is in the open position, a predetermined unit dose of the pharmaceutical composition can be easily squeezed into the receiving means, measured, and administered orally without spilling any of the composition from the containing means or the receiving means.

32. The system of claim 31, wherein the receptacle is a spoon bowl attached to the dispenser.

33. A system according to claim 30 wherein the composition has a Brookfield viscosity of 3500 to 65,000 cps.

34. A system according to claim 30 wherein the composition has a Brookfield viscosity of 6000 to 9000 cps.

35. A system according to claim 30 wherein the composition has a Brookfield viscosity of 7500 to 40,000 cps.

36. A system according to claim 30 wherein the pharmaceutical agent is dissolved.

37. A system according to claim 30 wherein the pharmaceutical agent is suspended.

38. A system according to claim 30 wherein the liquid base comprises propylene glycol.

39. A system according to claim 30, wherein the liquid base comprises propylene glycol in an amount up to 25%.

40. A system according to claim 30 wherein the liquid base comprises glycerin.

41. A system according to claim 30 wherein the liquid base comprises glycerin in an amount of 4% to 30%.

42. A system according to claim 30 wherein the liquid base is selected from the group consisting of water, propylene glycol, polyethylene glycol, glycerin, and mixtures thereof.

43. A system according to claim 30 wherein the thickening agent is selected from the group consisting of starch, modified starch, sodium carboxymethyl cellulose, microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, other cellulose derivatives, acacia, tragacanth, pectin, gelatin, polyethylene glycol, and water-soluble carboxyvinyl polymers.

44. A system according to claim 30, wherein the composition comprises hydrogenated glucose and/or sorbitol.

45. A system according to claim 30 wherein the thickening agent comprises 1% of a water-soluble carboxyvinyl polymer.

46. The system of claim 30, wherein, the pharmaceutical agent is selected from a member of the group consisting of an analgesic, non-steroidal anti-inflammatory, antihistamine, cough suppressant, expectorant, bronchodilator, anti-infective, CNS active drug, cardiovascular drug, antineoplastic, cholesterol-lowering drug, anti-emetic, and fecal softener.

47. The system of claim 30, wherein the pharmaceutical agent is selected from a member of the group consisting of acetaminophen, aspirin, ibuprofen, diphenhydramine, dextromethorphan, guaifenesin, pseudoephedrine, carbidopa, levodopa, terfenadine, ranitidine, ciprofloxacin, triazolam, fluconazole, propranolol, acyclovir, fluoxetine, enalapril, diltiazem, lovastatin and a pharmaceutically acceptable salt or ester thereof.
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